RESUMEN
Cholestyramine ointment is an hospital preparation used as a second-intention treatment for severe perianal skin lesions. These preparations have to be declared to AFSSAPS. The aim of this study was to assess the equivalence of Orabase, a marketed paste, with intention of substitution. A clinical trial was performed to evaluate the effectiveness of cholestyramine ointment versus Orabase paste. This study was conducted in the neonatalogy unit. The principal evaluation criterion was the time to clinical recovery. Nurses also gave their subjective evaluation of each product. Although 34 children were included in the study, the time to clinical recovery delay was evaluated in 28. Time to clinical recovery was 90.5 hours for the cholestyramine ointment and 81 hours for Orabase paste. Concerning the subjective assessment, Orabase paste achieved a higher score than cholestyramine ointment (p<0.01). Orabase paste was considered to be equivalent to cholestyramine ointment.
Asunto(s)
Carboximetilcelulosa de Sodio/análogos & derivados , Enfermedades de la Piel/tratamiento farmacológico , Nalgas , Carboximetilcelulosa de Sodio/uso terapéutico , Resina de Colestiramina/uso terapéutico , Femenino , Hospitalización , Humanos , Recién Nacido , Masculino , Pomadas , Índice de Severidad de la EnfermedadRESUMEN
UNLABELLED: Maternal opioid abuse during pregnancy results in 60 to 95% of neonatal withdrawal. The literature review on the evaluation of the severity of the related symptoms and treatments used shows an absence of consensus. MATERIALS AND METHODS: To survey the management of the neonatal withdrawal a questionnaire was sent to French and other European pharmacists. RESULTS: Fifty-eight questionnaires were returned, 37 from France. In 74%, a written protocol about the management of the neonatal withdrawal was available. The severity of the symptoms was assessed using the Finnegan's scale in 55% of the cases and the treatment was a substitute opiate in 72.5%. In 64% of the cases, this drug was an oral morphine solution: a hydrochloride solution in France and a sulfate solution in other E.U countries at the most common dose of 0.5 to 1mg x kg(-1) x d(-1) and 0.24 mg x kg(-1) x d(-1) respectively. DISCUSSION: The solution used in France is contra-indicated in infants less than six months and the presentation is not adapted to this use. CONCLUSION: This morphine survey points out that a preparation intended for infants should be developed and licensed in this indication to improve the use of treatment.
Asunto(s)
Analgésicos Opioides/farmacología , Intercambio Materno-Fetal , Morfina/farmacología , Síndrome de Abstinencia Neonatal/tratamiento farmacológico , Trastornos Relacionados con Opioides , Guías de Práctica Clínica como Asunto , Adulto , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/efectos adversos , Europa (Continente) , Femenino , Francia , Encuestas de Atención de la Salud , Humanos , Lactante , Recién Nacido , Morfina/administración & dosificación , Morfina/efectos adversos , Planificación de Atención al Paciente , Embarazo , Complicaciones del Embarazo , Índice de Severidad de la EnfermedadRESUMEN
KRAS2 mutations in codon 12 have been detected in about 80% of pancreatic cancers. The aim of this study was to evaluate the value of KRAS2 mutations detection in circulating deoxyribo nucleic acid to differentiate pancreatic cancer from chronic pancreatitis. Circulating deoxyribonucleic acid was isolated from serum in 47 patients with histologically proven pancreatic adenocarcinomas (26 males, median age 65 years) and 31 controls with chronic pancreatitis (26 males, median age 48 years). Mutations at codon 12 of KRAS2 gene were searched for using polymerase chain reaction and allele specific amplification. Serum carbohydrate antigen 19.9 levels were also determined. KRAS2 mutations were found in 22 patients (47%) with pancreatic cancer and in four controls with chronic pancreatitis (13%) (P<0.002). None of the latter developed a pancreatic cancer within the 36 months of median follow-up. The sensitivity, specificity, positive and negative predictive values of serum serum KRAS2 mutations for the diagnosis of pancreatic cancer were 47, 87, 85 and 52%, respectively. KRAS2 mutations were not related to age, gender, smoking habit, tumour stage, or survival. Among the 26 patients with normal or non-contributive (due to cholestasis) serum carbohydrate antigen 19.9 levels, 14 (54%) had KRAS2 mutations. The combination of KRAS2 and carbohydrate antigen 19.9 gave a sensitivity, specificity, positive and negative predictive values for the diagnosis of pancreatic cancer of 98, 77, 87 and 96%, respectively. Detection of KRAS2 mutations in circulating deoxyribo nucleic acid has a low sensitivity but a specificity about 90% for the diagnosis of pancreatic cancer. It seems particularly useful when serum carbohydrate antigen 19.9 levels are normal or inconclusive. A combined normal serum carbohydrate antigen 19.9 and absence of circulating KRAS2 mutations makes the diagnosis of pancreatic cancer extremely unlikely.
Asunto(s)
Adenocarcinoma/diagnóstico , Biomarcadores de Tumor/sangre , Antígeno CA-19-9/sangre , ADN/genética , Genes ras , Neoplasias Pancreáticas/diagnóstico , Pancreatitis/diagnóstico , Adenocarcinoma/sangre , Adenocarcinoma/genética , Adenocarcinoma/mortalidad , Adenocarcinoma/terapia , Anciano , Anciano de 80 o más Años , Alelos , Enfermedad Crónica , Codón/genética , ADN/sangre , Análisis Mutacional de ADN , Femenino , Estudios de Seguimiento , Amplificación de Genes , Humanos , Masculino , Persona de Mediana Edad , Células Neoplásicas Circulantes , Neoplasias Pancreáticas/sangre , Neoplasias Pancreáticas/genética , Neoplasias Pancreáticas/mortalidad , Neoplasias Pancreáticas/terapia , Pancreatitis/sangre , Pancreatitis/genética , Reacción en Cadena de la Polimerasa , Valor Predictivo de las Pruebas , Sensibilidad y Especificidad , Fumar/epidemiología , Análisis de SupervivenciaRESUMEN
MATERIALS AND METHODS: Three surveys were successively carried out regarding aminoglycoside use: one analysis of amikacine prescriptions in the most prescribing clinical wards and two surveys among nurses and physicians respectively on prescribing, administering and monitoring aminoglycosides. RESULTS: On 43 amikacine prescriptions analyzed in a month, one daily dose infusion in 30 minutes was observed in most of the patients (70%), doses and indications matched most often the official license. Half of patients treated for more than five days had no drug level monitoring. Sample collection by nurses was very erratic making results obtained not interpretable. CONCLUSION: Subsequently, guidelines regarding aminoglycoside use were designed by the interest group, approved by the drug committee and sent to all hospital prescribers and nurses.
Asunto(s)
Amicacina/uso terapéutico , Antibacterianos/uso terapéutico , Adolescente , Niño , Preescolar , Utilización de Medicamentos/estadística & datos numéricos , Hospitales Pediátricos , Humanos , Lactante , Estudios ProspectivosRESUMEN
The analytical and microbiological stability of meglumine gadoterate (Dotarem) repackaged in polypropylene syringe for 3 months at either +4 degrees C or room temperature was studied. For analytical study: six polypropylene syringes (20 ml) were filled with 15 ml of meglumine gadoterate. Three syringes were stored at 4+/-2 degrees C and three at 25+/-2 degrees C, all syringes were kept upright and protected from daylight. Samples were taken on days 0, 6, 14, 30, 45, 60, 75 and 90. Meglumine gadoterate and its degradation product (free Gd3+) concentrations were obtained using a specific HPLC assay. Osmolality and pH determination were made on days 0, 14, 45 and 90. For microbiological study: 28 plastic syringes (5 ml) were filled with 2.5 ml of meglumine gadoterate. Syringes were stored at 25+/-2 degrees C and protected from daylight. At each day of analysis (0, 15, 35, 45, 60, 75 and 90), four syringes were tested as described in European Pharmacopoeia. After 90 days the concentration of gadoterate remained unchanged and no free Gd3+ were detected. The injectable solution of this gadolinium contrast agent was sterile according to European Pharmacopoeia guidelines. The meglumine gadoterate repackaged in polypropylene syringe was stable for 3 months at all the temperatures studied.